MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN STAT; ARCTIC SUN DEVICE

Catalog Number	60000000L
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they just started normothermia at 9pm.The arctic sun device appears to be heating the patient rather than cooling.Patient temperature (pt) was 36.9c, targeted temperature (tt) was 36.5c, water temperature (wt) was 40.2c, water flow rate (wfr) was 1.1 l/m.Esophageal probe and rectal probe correlate.No shivering, seizures or micro-shivering.Nurse denied any alerts/alarms.System diagnostics showed that the outlet monitor temperature (t1) was 39.6c, outlet control temperature (t2) was 39.6c, inlet temperature (t3) was 39.9c, chiller temperature (t4) was 4.6c, water flow rate (wfr) was 0.9 l/m, inlet pressure (ip) was -7 psi, circulation pump command (cpc) was 31 percentage, mixing pump command (mpc) was 0, heater was 3 percentage, water reservoir level (wrl) was 5, system hours were 2646.2.Advised device did have heater enabled and appears to be warming.Had stop therapy and restart.Water temperature immediately began adjusting and dropping from 38c to 25.9c.Advised to monitor for the next hour and noted water temperature (wt) should not be increasing if patient temperature (pt) was above the targeted temperature (tt).Encouraged to call back with any questions or concerns.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that they just started normothermia at 9pm.The arctic sun device appears to be heating the patient rather than cooling.Patient temperature (pt) was 36.9c, targeted temperature (tt) was 36.5c, water temperature (wt) was 40.2c, water flow rate (wfr) was 1.1 l/m.Esophageal probe and rectal probe correlate.No shivering, seizures or micro-shivering.Nurse denied any alerts/alarms.System diagnostics showed that the outlet monitor temperature (t1) was 39.6c, outlet control temperature (t2) was 39.6c, inlet temperature (t3) was 39.9c, chiller temperature (t4) was 4.6c, water flow rate (wfr) was 0.9 l/m, inlet pressure (ip) was -7 psi, circulation pump command (cpc) was 31 percentage, mixing pump command (mpc) was 0, heater was 3 percentage, water reservoir level (wrl) was 5, system hours were 2646.2.Advised device did have heater enabled and appears to be warming.Had stop therapy and restart.Water temperature immediately began adjusting and dropping from 38c to 25.9c.Advised to monitor for the next hour and noted water temperature (wt) should not be increasing if patient temperature (pt) was above the targeted temperature (tt).Encouraged to call back with any questions or concerns.Per follow up information received via task on 14may2025, spoke with charge nurse who confirmed therapy had been completed on the device without further issue.Their tm had retrieved the device a couple days later for the loaner return.
Additional Manufacturer Narrative
The reported issue was unconfirmed.The root cause of the reported event could not be determined.Reported issue was not reproduced during service.The device was evaluated upon receipt.During the evaluation it was found that the reported issue was not confirmed.A crack on the right side of the outer shell.A crack on the outer shell.The crack on the outer shell was cosmetic and did not affect function.The arctic sun passed functionality testing in compliance with manufacturer specifications, functions normally and is ready for use.The reported event is unconfirmed the risk review is not required.The reported event is unconfirmed, dhr review is not required the reported event is unconfirmed, labeling/packaging review is not required.Correction: d, h.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: ARCTIC SUN STAT
• Common Device Name: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21738691
• Report Number: 1018233-2025-02171
• Device Sequence Number: 18392835
• Product Code: DWJ
• UDI-Device Identifier: 00801741161520
• UDI-Public: (01)00801741161520(11)200805
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 60000000L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown